We are supporting a Pharmaceutical business as they seek to bring on board a new Head of Regulatory Affairs to join them at an exciting phase of growth.
About the business:
This organisation is well established, has a diverse customer base, and is well geared for growth in the coming years. The business supplies a range of pharmaceutical products into multiple segments of the healthcare sector and has a strong reputation as one of the leaders within this field.
They have a diverse and inclusive culture, and you will get the opportunity to not only lead and work alongside a talented regulatory affairs team but also work cross-functionally with the wider business. The Head of Regulatory Affairs will be an integral part of the success of the business moving forward, so it is paramount that the individual who comes on board is committed to joining a business for the long-term and ready to make a real impact within the company.
About the role:
The Head of Regulatory Affairs will lead the Regulatory Affairs team and is responsible for maintaining/reviewing existing licenses as well as implementing new licenses. You will have overall responsibility for contributing towards optimum levels of regulatory compliance and supporting the wider business with achieving its commercial goals.
Some of the key responsibilities for the Head of Regulatory Affairs role will involve:
1. Leading the Regulatory Affairs team, including all line management responsibilities.
2. Ensuring that all licenses comply with the regulations set by the Regulatory Authority.
3. Ensuring timely submission of all new license applications and license variations by the Regulatory Affairs team.
4. Ensuring all members of the Regulatory Affairs team are adequately trained to perform the tasks required.
5. Acting as a point of contact for all external stakeholders, including MHRA and license users.
6. Training, mentoring, and developing members of the Regulatory Affairs team.
7. Continuously improving the operating standards utilized across the team, achieving a continuous improvement culture.
8. Submitting New Applications/Notifications in a timely manner to ensure meeting customer expectations.
9. Keeping all license portfolios continuously up to date with the latest requirements from the regulatory bodies and free from errors.
The successful candidate for the Head of Regulatory Affairs role will have the following background:
1. Extensive experience working in a leadership/management role within a Regulatory Affairs team in the Pharmaceutical sector.
2. Strong knowledge and understanding of regulatory processes in GMP environments.
3. A solution-oriented individual who focuses on practical resolutions to problems.
4. We are open to considering those seeking their first no. 1 role in Regulatory Affairs management/leadership - if you are an aspiring Regulatory Affairs professional and feel ready to take on your first "Head of" role in your career, we want to hear from you!
For a more detailed JD and conversation about the role, please do get in touch.
Please note - our client are unable to provide visa sponsorship and we are therefore only able to accept applications from candidates who have full right to work in the UK.
Keywords:
Head of Regulatory Affairs, Regulatory Affairs Manager, Pharmaceutical, GMP
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